Expired Study
This study is not currently recruiting Study Participants on ClinicalConnection.com. If you would like to find active studies please search for clinical trials.

Rochester, Minnesota 55905


Purpose:

To assess attitudes toward screening for esophageal adenocarcinoma (EAC) and Barrett's esophagus (BE) in the community. To develop a population based clinical risk factor prediction model for the diagnosis of BE and identify novel risk factors for BE which would make population based screening more efficient. This will be an important first step in identifying the target population for BE screening, another crucial component of making screening feasible and efficient


Criteria:

Inclusion Criteria: 1. Case: Olmsted county residents > 18 years old from the barrett's esophagus (BE) incidence cohort who are still alive at the time of study. 2. Control # 1 : Olmsted county residents > 18 years old that responded to a recent community based survey and reported gastroesophageal reflux (GER) symptoms at least once a week and without a known diagnosis of BE. 3. Control # 2 : Olmsted county residents > 18 years old that responded to a recent community based survey that did not report any GER symptoms and without a known diagnosis of BE. Exclusion Criteria: 1. Cases: BE subjects who 1. Have died prior to the start of this study; 2. Refuse to participate; 2. Controls: respondents to the "constipation survey" who 1. Are known to have BE; 2. Have died prior to the start of this study; 3. Refuse to participate; -


Study is Available At:


Original ID:

09-002718


NCT ID:

NCT01286155


Secondary ID:


Study Acronym:


Brief Title:

Epidemiology of Barrett's Esophagus: A Population Based Study


Official Title:

Epidemiology of Barrett's Esophagus: A Population Based Study


Overall Status:

Completed


Study Phase:

N/A


Genders:

Both


Minimum Age:

18 Years


Maximum Age:

95 Years


Quick Facts

Healthy Volunteers
Oversight Has DMC
Study Is FDA Regulated
Study Is Section 801
Has Expanded Access

Study Source:

Mayo Clinic


Oversight Authority:

United States: Institutional Review Board


Reasons Why Stopped:


Study Type:

Observational


Study Design:

Observational Model: Cohort, Time Perspective: P


Number of Arms:

0


Number of Groups:

3


Total Enrollment:

534


Enrollment Type:

Actual


Study Dates

Start Date:January 2010
Completion Date:June 2011
Completion Type:Actual
Primary Completion Date:June 2011
Primary Completion Type:Actual
Verification Date:May 2013
Last Changed Date:May 3, 2013
First Received Date:January 26, 2011

Study Outcomes

Outcome Type:Secondary Outcome
Measure:Study established (age, gender, ethnicity, reflux) and potential risk factors (sleep apnea, visceral adiposity, Helicobacter pylori infection, Metabolic Syndrome)to develop a clinical risk factor model for diagnosis of Barrett's esophagus(BE).
Time Frame:18 months
Safety Issues:False
Description:Metabolic Syndrome (ATP III criteria, JAMA 2001; 285: 2486-97.) defined as a combination of clinical disorders that includes the presence of three or more of the following indicators: abdominal obesity (waist circumference > 102 cm in men, > 88 cm
Outcome Type:Primary Outcome
Measure:The primary outcome from the survey will be the proportion of patients willing to undergo an esophageal capsule study compared to those willing to undergo an endoscopic procedure (Esophagogastroduodenoscopy or transnasal endoscopy)
Time Frame:18 months
Safety Issues:False

Study Interventions

There are no available Study Interventions

Study Arms

Study Arm Type:Other
Arm Name:with gastroesophageal reflux disease(GERD)
Description:Subjects with gastroesophageal reflux disease (GERD)
Study Arm Type:Other
Arm Name:Non-GERD
Description:Subjects with no history of gastroesophageal reflux disease (GERD)
Study Arm Type:Other
Arm Name:Barrett's esophagus
Description:Subjects with confirmed barrett's esophagus in Olmsted county

Study Agencies

Agency Class:Other
Agency Type:Lead Sponsor
Agency Name:Mayo Clinic
Agency Class:Other
Agency Type:Collaborator
Agency Name:American College of Gastroenterology

Samples and Retentions

Sample Retention:Samples With DNA
Description: Blood
Study Population: Olmsted county resident
Sample Method:Non-Probability Sample

Study References

There are no available Study References

Data Source: ClinicalTrials.gov

Date Processed: October 09, 2019

Modifications to this listing: Only selected fields are shown, please use the link below to view all information about this clinical trial.


This study is not currently recruiting Study Participants. The form below is not enabled.